OUZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3870
- Medical specialty
- Microbiology
- FDA definition
- Detection of Leishmania species in skin lesions.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SMART LEISH, MODEL LGM1-050 (K081868) | U.S. Army Medical Research Institute of Infectious | 2011-05-25 |
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